The pharmacologic agent utilized in the method of the instant invention is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]-propyl]-4,5-diethyl-1,2,4-triazol- 3-one, also known as etoperidone ("USAN and the USP Dictionary of Drug Names", 1988 Edition; M. C. Griffith, Editor, U.S. Pharmacopeial Convention, Inc., Mack Printing Co., Easton, Pa., page 217).
Etoperidone has been disclosed as having hypotensive and analgesic activities (Palazzo; U.S. Pat. No. 3,857,845) and as being of use in treating Parkinsonism and other extra-pyramidal syndromes characterized by tremors (Silvestrini; U.S. Pat. Nos. 4,132,791; 4,162,318). The pharmacology of etoperidone has been extensively detailed by Lisciani, et al., Arzneim. Forsch/Drug Research (1978) 28 (II), pp. 417-423.
Pertaining to the use envisioned in the instant invention, the antidepressant drug, 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]-propyl]-1,2,4-triazolo[4,3-a]pyrid in-3(2H)-one (also known as trazodone) and its salts have been disclosed as being useful in treating male impotence (Gamble, et al., U.S. Pat. No. 4,687,771 and pending application U.S. Ser. No. 070,851). Direct penile injection of certain vasodilators and/or adrenergic blocking agents for the purpose of causing penile erections has also been disclosed (Latorre; U.S. Pat. No. 4,127,118). Currently, yohimbine is being studied for possible use in the treatment of impotence.
Male impotence is a sexual dysfunction which relates to difficulty in achieving and/or maintaining penile erection sufficiently rigid for satisfactory coitus. Currently, male impotence is a broad-ranging problem of social, psychologic, and medical significance. There exists today a diversity of possible causes of impotence as well as suggested methods of treatment. These have been described in a number of available literature reviews on male impotence and on male sexual dysfunctioning in general. While impotence can result from psychogenic or physical causes, a review by L. M. Martin in Geriatrics, (December 1980), pages 79-83; emphasizes that organic causes of impotence are more common than has been currently believed. Any condition that impairs the endocrine, vascular, neurologic, or anatomic systems that pertains to the erectile mechanism can produce impotence. The various causes of impotence that have been specifically implicated are: diabetes, radical pelvic surgery, peripheral vascular disease, hypertension and hardening of arteries, side-effects from drugs, and hormonal imbalance.
Concerning the treatment of impotence, H. G. Kudish in Postgraduate Medicine, Vol. 74/4 (October 1983), pages 233-240; lists therapies for impotence as being in two categories: surgical and non-surgical. The surgical category comprises implantation of a penile prosthetic device; revascularization of the arteries of the penis; ligation/excision of the veins draining the penis and incision or excision of Peyronie's plaques. The non-surgical category comprises sex therapy, endocrine therapy, pharmacologic therapy, and electrostimulation. Non-surgical therapies, when effective, are the treatments of choice. Of these, the favored treatment in most instances would be oral pharmacologic therapy if it was effective. Unfortunately, the use of oral pharmacologic agents in the treatment of impotence has achieved little success. This is evidenced by the absence of any widely accepted oral pharmacologic treatment for use in male impotence. Although anecdotal reports regarding various agents, compositions, and formulations to be employed for this purpose abound.
Considering the present state of the art, there exists nothing in the prior art which teaches or suggests that etoperidone would be useful in the treatment of impotence in males with compromised penile erection function.